Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes (DPPCooks)
Primary Purpose
Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DPP Cooks
DPP
Sponsored by
About this trial
This is an interventional prevention trial for Pre-diabetes
Eligibility Criteria
Inclusion Criteria:
- Adults in Baltimore City
- eligible for DPP based on Centers for Disease Control guidelines
- possession of a smart phone with camera
- can commit to 12 month study participation
Exclusion Criteria:
- current or prior diagnosis of type 1- or type 2 diabetes
- non-English speaker
- participating in another research study that may effect diabetes, diet, or weight loss
- currently pregnant
Sites / Locations
- Brancati Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard DPP
DPP Cooks
Arm Description
Standard DPP (over 12 months)
Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months)
Outcomes
Primary Outcome Measures
Change from baseline in body weight (kilograms (kg) and percent of baseline bodyweight)
Weight change will be measured in absolute kg and in the percent of body weight lost. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings).
Secondary Outcome Measures
Difference from baseline in diet quality (Healthy Eating Index- 2015) score.
Dietary intake and diet quality (Healthy Eating Index (HEI-2015) as measured by the Remote Food Photography Method (RFPM) over 3 days at baseline and 4 months. The HEI-2015 is a score from 0-100 with high score indicating better diet quality. The HEI-2015 measures how well an individuals dietary intake aligns with the 2015 US Dietary Guidelines.
Change from baseline in cooking confidence, attitudes, and behavior
Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months.
Change from baseline in Food Agency measured via the Cooking and Food Provisioning Action Scale (CAFPAS)
The Cooking and Food Provisioning Action Scale (CAFPAS) is a 28 questions scale in which higher scores indicate higher Food Agency. All questions in the CAFPAS are measured on 7-point Likert Scales (strongly agree to strongly disagree). The CAFPAS has 3 sub-scales which are scored by summing the scores on each individual question and are then standardized. Then the 3 standardized sub-scale scores are summed to generate an overall CAFPAS score in which higher scores indicate better Food Agency.
Change from baseline in food security status over the past 30 days using the 10-item United States Department of Agriculture (USDA) adult food security survey module
The USDA Adult Food Security Survey Module is a 10-item progressive survey instrument in which individuals are asked about the food situation in their household over the last 30 days. Scores are summed and generate the following categories: High food security status (raw score: 0), Marginal food security status (raw score: 1-2), Low food security status (raw score 3-5), Very low food security status (raw score: 6-10).
Full Information
NCT ID
NCT05166512
First Posted
December 8, 2021
Last Updated
October 5, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05166512
Brief Title
Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes
Acronym
DPPCooks
Official Title
Development and Pilot Evaluation of a Novel Cooking Skills Intervention to Prevent Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
October 4, 2023 (Actual)
Study Completion Date
October 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this pilot trial participants will be randomized 1:1 to participate in either standard Diabetes Prevention Program (DPP) vs. DPP plus a novel cooking skills intervention (DPP Cooks). The researchers hypothesize that participants randomized to DPP Cooks will have greater weight loss, better diet quality at 4 months, and greater confidence in their cooking skills and ability to implement dietary changes recommended in the DPP.
Detailed Description
This study is a randomized pilot trial testing a novel cooking skills intervention (DPP Cooks) vs. the standard Diabetes Prevention Program (DPP). The DPP is a widely disseminated evidenced-based lifestyle behavior change program to help adults with pre-diabetes lose weight and prevent type-2 diabetes. In this trial the investigators will test whether the addition of food-agency based cooking skills classes improves the effectiveness of the DPP. This trial will take place in Baltimore, MD in collaboration with community partner DPP providers. The trial has been informed by formative work with prior DPP participants and has used a Community Based Participatory Research (CBPR) approach to developing the DPP Cooks intervention. Participants will be randomized 1:1 to participate in either standard DPP vs. DPP Cooks. The length of the trial will be 12 months and outcomes will be measured at baseline, 4 months, and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard DPP
Arm Type
Active Comparator
Arm Description
Standard DPP (over 12 months)
Arm Title
DPP Cooks
Arm Type
Experimental
Arm Description
Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months)
Intervention Type
Behavioral
Intervention Name(s)
DPP Cooks
Intervention Description
6 'food agency' based cooking skills classes during the first 4 months of the DPP
Intervention Type
Behavioral
Intervention Name(s)
DPP
Intervention Description
Standard DPP
Primary Outcome Measure Information:
Title
Change from baseline in body weight (kilograms (kg) and percent of baseline bodyweight)
Description
Weight change will be measured in absolute kg and in the percent of body weight lost. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings).
Time Frame
baseline, 4 months and 12 months
Secondary Outcome Measure Information:
Title
Difference from baseline in diet quality (Healthy Eating Index- 2015) score.
Description
Dietary intake and diet quality (Healthy Eating Index (HEI-2015) as measured by the Remote Food Photography Method (RFPM) over 3 days at baseline and 4 months. The HEI-2015 is a score from 0-100 with high score indicating better diet quality. The HEI-2015 measures how well an individuals dietary intake aligns with the 2015 US Dietary Guidelines.
Time Frame
3 days of dietary intake data at baseline and at 4 months
Title
Change from baseline in cooking confidence, attitudes, and behavior
Description
Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months.
Time Frame
baseline, 4 months and 12 months
Title
Change from baseline in Food Agency measured via the Cooking and Food Provisioning Action Scale (CAFPAS)
Description
The Cooking and Food Provisioning Action Scale (CAFPAS) is a 28 questions scale in which higher scores indicate higher Food Agency. All questions in the CAFPAS are measured on 7-point Likert Scales (strongly agree to strongly disagree). The CAFPAS has 3 sub-scales which are scored by summing the scores on each individual question and are then standardized. Then the 3 standardized sub-scale scores are summed to generate an overall CAFPAS score in which higher scores indicate better Food Agency.
Time Frame
baseline, 4 months and 12 months
Title
Change from baseline in food security status over the past 30 days using the 10-item United States Department of Agriculture (USDA) adult food security survey module
Description
The USDA Adult Food Security Survey Module is a 10-item progressive survey instrument in which individuals are asked about the food situation in their household over the last 30 days. Scores are summed and generate the following categories: High food security status (raw score: 0), Marginal food security status (raw score: 1-2), Low food security status (raw score 3-5), Very low food security status (raw score: 6-10).
Time Frame
baseline, 4 months and 12 months
Other Pre-specified Outcome Measures:
Title
Program attendance among DPP and DPP Cooks participants
Description
DPP coaches will report weekly session attendance for all trial participants. Attendance at a higher number of sessions will be a favorable result.
Time Frame
12 months
Title
Program satisfaction among DPP Cooks participants (qualitative)
Description
Investigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults in Baltimore City
eligible for DPP based on Centers for Disease Control guidelines
possession of a smart phone with camera
can commit to 12 month study participation
Exclusion Criteria:
current or prior diagnosis of type 1- or type 2 diabetes
non-English speaker
participating in another research study that may effect diabetes, diet, or weight loss
currently pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia A Wolfson, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brancati Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes
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